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FDA 510(k)

Concerto Versa, Detachable Coil

K-Number: K202850 · 2021-02-09

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2021-02-09
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Concerto Versa, Detachable Coil is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2021-02-09 under approval number K202850. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Concerto Versa, Detachable Coil?

Concerto Versa, Detachable Coil is a medical device that received FDA 510(k) clearance on 2021-02-09. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K202850.

When was Concerto Versa, Detachable Coil approved by the FDA?

Concerto Versa, Detachable Coil received FDA 510(k) clearance on 2021-02-09, under approval number K202850.

What company makes Concerto Versa, Detachable Coil?

Concerto Versa, Detachable Coil is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

What is the FDA product code for Concerto Versa, Detachable Coil?

The FDA product code for Concerto Versa, Detachable Coil is KRD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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